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FDA 510(k)

ICONN Square 2.5MM Suture Anchor

K-Number: K172491 · 2017-11-29

ApplicantIconn Orthopedics, LLC
Decision Date2017-11-29
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ICONN Square 2.5MM Suture Anchor is a medical device manufactured by Iconn Orthopedics, LLC. It received FDA 510(k) clearance on 2017-11-29 under approval number K172491. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICONN Square 2.5MM Suture Anchor?

ICONN Square 2.5MM Suture Anchor is a medical device that received FDA 510(k) clearance on 2017-11-29. It is manufactured by Iconn Orthopedics, LLC. The 510(k) number is K172491.

When was ICONN Square 2.5MM Suture Anchor approved by the FDA?

ICONN Square 2.5MM Suture Anchor received FDA 510(k) clearance on 2017-11-29, under approval number K172491.

What company makes ICONN Square 2.5MM Suture Anchor?

ICONN Square 2.5MM Suture Anchor is manufactured by Iconn Orthopedics, LLC.

What is the FDA product code for ICONN Square 2.5MM Suture Anchor?

The FDA product code for ICONN Square 2.5MM Suture Anchor is MBI.

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Iconn Orthopedics, LLC

K180670ICONN Campbell Interference Screw K182264ICONN Revolution Knotless Suture Anchor K181680ICONN Answer II Suture Anchor

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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